WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS).
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION OF DIDANOSINE AND STAVUDINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL RISK (SEE WARNINGS AND PRECAUTIONS: PREGNANCY, REPRODUCTION, AND FERTILITY).
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VIDEX SUMMARY
VIDEX® (didanosine) is a brand name for didanosine (ddI), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). VIDEX Pediatric Powder for Oral Solution is supplied for oral administration in 4- or 8-ounce glass bottles containing 2 or 4 grams of didanosine, respectively. Didanosine is also available as an enteric-coated formulation (VIDEX® EC Delayed-Release Capsules). Please consult the prescribing information for VIDEX EC (didanosine).
VIDEX (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.
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NEWS HIGHLIGHTSMedia Articles Related to Videx (Didanosine)
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
Published Studies Related to Videx (Didanosine)
Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). [2011.01]
BACKGROUND: once-daily combinations of efavirenz and two nucleoside analogues are recommended for the treatment of HIV infection. Long-term efficacy and safety data are scarce for the combination of efavirenz, emtricitabine and didanosine... CONCLUSIONS: a once-daily regimen of emtricitabine, didanosine and efavirenz provided a durable antiretroviral response and was well tolerated through 4 years of therapy.
Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. [2009.05.01]
BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa... CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART.
Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. [2008.10.15]
BACKGROUND: The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials... CONCLUSIONS: At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. CLINICAL TRIALS REGISTRATION: NCT00256828.
Low-level K65R mutation in HIV-1 reverse transcriptase of treatment-experienced patients exposed to abacavir or didanosine. [2007.10.01]
BACKGROUND: Prior abacavir (ABC) or didanosine (ddI) therapy can result in the L74V/I or K65R mutation in HIV-1 reverse transcriptase. Preexisting K65R may have an impact on the treatment response to tenofovir disoproxil fumarate (TDF)... CONCLUSIONS: Prior therapy with ABC or ddI can result in a population genotype that shows K65R or L74V/I but does not reveal low-level K65R present in some patients. Subsequent treatment intensification with TDF resulted in a poor virologic response and may result in expansion of the preexisting K65R mutant.
Stavudine but not didanosine as part of HAART contributes to peripheral lipoatrophy: a substudy from the Antiretroviral Regimen Evaluation Study (ARES). [2007.09]
CONCLUSION: This study suggests that didanosine/lamivudine, when combined with either nevirapine or ritonavir-boosted saquinavir over 96 weeks of therapy, is possibly not associated with limb fat atrophy, in contrast to when treatment contained didanosine, stavudine, and nelfinavir combined.
Clinical Trials Related to Videx (Didanosine)
Bioequivalence Study of Didanosine in Children Treated for HIV [Not yet recruiting]
The purpose of this study is to show that the administration of 400/mg/m2/day of
didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of
didanosine during fasting, in HIV infected children treated by a ARV combination including
ddI
Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV co-Infected Patients [Recruiting]
The primary purpose of this study is to evaluate the impact of changing didanosine in an
effective anti-HIV regimen to tenofovir on virologic suppression. We hypothesize that, in
patients with maximal virologic suppression on a double class regimen (including two NRTIs
and an NNRTI or a PI, boosted with RTV or not), a single drug substitution of didanosine for
tenofovir will represent a viable strategy without any negative impact on the virologic
efficacy of the regimen.
Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé) [Recruiting]
Since the first line antiretroviral (ARV) treatment is now largely accessible in the
Sub-Saharian Africa countries, documentation of virological failure, drug resistance
patterns and second line treatment evaluation are still to be consolidated in settings where
viral load monitoring is not available and non-B HIV subtype is predominant.
This trial aims at evaluating the efficacy and tolerance of 3 different second line
treatment strategies: two recommended by WHO combine two non-nucleoside reverse
transcriptase inhibitor associated with a ritonavir boosted protease inhibitor
(emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir);
the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet
evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a
better tolerance and its single daily administration may facilitate treatment adherence.
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children [Recruiting]
The primary purpose of this study is to find the dose of Efavirenz for young children. The
safety and how the medication is tolerated will also be studied.
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth [Recruiting]
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given
to HIV infected pregnant women during and after their pregnancies is most effective in
reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and
lopinavir/ritonavir (LPV/r) will also be studied.
Study hypothesis: NVP resistance following single-dose NVP can be prevented with the
concomitant administration of additional antiretroviral therapy (ART).
Reports of Suspected Videx (Didanosine) Side Effects
Renal Failure Acute (9),
Multi-Organ Failure (6),
Nephrolithiasis (6),
Fanconi Syndrome (6),
Weight Decreased (5),
Lipodystrophy Acquired (5),
Drug Resistance (5),
Hyperlipidaemia (5),
Diarrhoea (5),
Pancreatitis Acute (4), more >>
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Page last updated: 2013-05-04
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